2
Superior long term outcomes in complex real-world patients 6,7,8 Sustained safety and efficacy for at least 3 years in 5400 real-world patients 5 Lowest very late stent thrombosis in all-comer trials 9 Over 20'300 patients have been treated with BioMatrix Family stents in various randomized controlled trials Ordering Information Stent Diameter (mm) 9 14 19 24 29 33 36 2.25 BMX6-2209 BMX6-2214 BMX6-2219 BMX6-2224 BMX6-2229 2.50 BMX6-2509 BMX6-2514 BMX6-2519 BMX6-2524 BMX6-2529 BMX6-2533 BMX6-2536 2.75 BMX6-2709 BMX6-2714 BMX6-2719 BMX6-2724 BMX6-2729 BMX6-2733 BMX6-2736 3.00 BMX6-3009 BMX6-3014 BMX6-3019 BMX6-3024 BMX6-3029 BMX6-3033 BMX6-3036 3.50 BMX6-3509 BMX6-3514 BMX6-3519 BMX6-3524 BMX6-3529 BMX6-3533 BMX6-3536 4.00 BMX6-4009 BMX6-4014 BMX6-4019 BMX6-4024 BMX6-4029 Stent Length (mm) www.biosensors.com BIOSENSORS EUROPE SA Rue de Lausanne 29 1110 Morges Switzerland Tel: +41 (0)21 804 80 00 Fax: +41 (0)21 804 80 01 BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD 36 Jalan Tukang Singapore 619266 Tel: +65 6213 5777 Fax: +65 6213 5737 11582-000-EN - Rev.01 Excellent Long Term Safety and Efficacy 4 BioMatrix Alpha™ drug eluting stent system is CE approved. CAUTION: ﬔe law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. BioMatrix NeoFlex, BioMatrix Flex, Juno, Quadrature Link, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. All cited trademarks are the property of their respective owners. Not available for sale in the United States and certain other countries. © 2016. Biosensors International Group, Ltd. All rights reserved. 1. Biosensors International internal bench testing performed on 3.0 mm stents. Data on file at Biosensors International 2. Percentage change in stent length aſter applying 5N compression force longitudinally 3. Recoil measured as percentage change in diameter at RBP 4. ﬔis data is related to BioMatrix Family, which has the exact same coating and equivalent pharmacokinetics as BioMatrix Alpha 5. Hildick-Smith D et al. EuroPCR 2015 6. Windecker S et al. Lancet. 2008; 372:1163-73 7. Serruys PW, et al. JACC Cardiovasc Interv. 2013; 6:777-89 8. Räber L, et al. Circ Cardiovasc Interv. 2014; 7:355-64 9. Stefanini G, Windecker S. Circulation Card Intv 2012; 5:332-5 10. De Cock D, et al. Cardiovascular Imaging. 2014; 15-900-09 11. Lüscher TF, et al. Circulation. 2007; 115:1051-58 12. Farb A, et al. Circulation. 2003; 108:1701–06 13. Joner M, et al. J Am Coll Cardiol. 2006; 48:193-202 14. Gladden LB. J Physiol. 2004; 558(1):5-30 15. Ghani, QP. et al. Methods in Enzymology. 2004; 381(36):565-75 16. Granada JF, SOLACI-CACI 2014 POCE: Composition of all death, all MI, all revascularization MACE: Composite of cardiac death, MI (target vessel MI in COMFORTABLE AMI study), ci-TVR ci-TVR: Clinically indicated Target Vessel Revascularization CD: Cardiac Death STEMI: ST-elevated Myocardial Infarction IDDM: Insulin-dependent Diabetes Mellitus CTO: Chronic Total Occlusion RRR: Relative Risk Reduction A very large international prospective registry 5 of the BioMatrix TM Family of stents in unselected patients demonstrates: Low cardiac death rate at 3 years (2.1%) Low myocardial infarction rate at 3 years (3.2%) Low target vessel revascularization rate at 3 years (5.6%) Low composite MACE rate at 3 years (9%) * MACE: A Composite of cardiac death, MI, or clinically indicated TVR Rates of very late definite stent thrombosis in all-comers randomized trials comparing DES at 3 years of follow-up 9 2.5 2.0 1.5 1.0 0.5 0 Event Rate (%) 2.0 1.6 1.4 0.9 0.7 0.4 0.3 0.2 50 40 30 20 10 0 ALL-COMERS POCE@5 yrs LEADERS RRR=16% STEMI CD@5 yrs LEADERS RRR=75% STEMI MACE@5 yrs LEADERS RRR=53% STEMI MACE@5 yrs COMFORTABLE AMI RRR=52% IDDM DEATH@5 yrs LEADERS RRR=50% CTO MACE@5 yrs Landmark @30 days LEADERS RRR=70% SYNTAX SCORE >12 MACE@5 yrs LEADERS RRR=29% Event Rate (%) P=0.024 P=0.007 P=0.008 P=0.0005 P=0.020 P=0.0197 P=0.021 BES SES BMS 40.4 35.1 11.8 3.1 11.9 5.8 37.7 21 35.3 13.1 30.3 22.7 25.7 13.1 0 6 12 18 24 30 36 Months 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 Event Rate (%) 9.0 5.6 3.2 2.1 Cardiac Death MI CV-TLR MACE * Power to Heal Powered by Power to Heal

Excellent Long Term Safety and Efficacy · Excellent Long Term Safety and Efficacy 4 ... Biosensors International internal bench testing performed on 3.0 mm stents. Data on file

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Superior long term outcomes in complex real-world patients 6,7,8

Sustained safety and efficacy for at least 3 years in 5400 real-world patients5

Lowest very late stent thrombosis in all-comer trials9

Over 20'300 patients have been treated with BioMatrix Family stentsin various randomized controlled trials

Ordering Information

Stent Diameter (mm) 9 14 19 24 29 33 36

2.25 BMX6-2209 BMX6-2214 BMX6-2219 BMX6-2224 BMX6-2229

2.50 BMX6-2509 BMX6-2514 BMX6-2519 BMX6-2524 BMX6-2529 BMX6-2533 BMX6-2536

2.75 BMX6-2709 BMX6-2714 BMX6-2719 BMX6-2724 BMX6-2729 BMX6-2733 BMX6-2736

3.00 BMX6-3009 BMX6-3014 BMX6-3019 BMX6-3024 BMX6-3029 BMX6-3033 BMX6-3036

3.50 BMX6-3509 BMX6-3514 BMX6-3519 BMX6-3524 BMX6-3529 BMX6-3533 BMX6-3536

4.00 BMX6-4009 BMX6-4014 BMX6-4019 BMX6-4024 BMX6-4029

Stent Length (mm)

www.biosensors.com

BIOSENSORS EUROPE SA

Rue de Lausanne 291110 MorgesSwitzerlandTel: +41 (0)21 804 80 00Fax: +41 (0)21 804 80 01

BIOSENSORS INTERVENTIONALTECHNOLOGIES PTE LTD

36 Jalan TukangSingapore 619266Tel: +65 6213 5777Fax: +65 6213 5737 11

582-

000-

EN -

Rev.

01

Excellent Long Term Safety and Efficacy

4

BioMatrix Alpha™ drug eluting stent system is CE approved.

CAUTION: մեe law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructionsfor use can be found in the product labeling supplied with each device.

BioMatrix NeoFlex, BioMatrix Flex, Juno, Quadrature Link, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd.All cited trademarks are the property of their respective owners.

Not available for sale in the United States and certain other countries.© 2016. Biosensors International Group, Ltd. All rights reserved.

1. Biosensors International internal bench testing performed on 3.0 mm stents. Data on file at Biosensors International2. Percentage change in stent length after applying 5N compression force longitudinally3. Recoil measured as percentage change in diameter at RBP4. մեis data is related to BioMatrix Family, which has the exact same coating and equivalent pharmacokinetics as BioMatrix Alpha5. Hildick-Smith D et al. EuroPCR 20156. Windecker S et al. Lancet. 2008; 372:1163-737. Serruys PW, et al. JACC Cardiovasc Interv. 2013; 6:777-898. Räber L, et al. Circ Cardiovasc Interv. 2014; 7:355-649. Stefanini G, Windecker S. Circulation Card Intv 2012; 5:332-510. De Cock D, et al. Cardiovascular Imaging. 2014; 15-900-0911. Lüscher TF, et al. Circulation. 2007; 115:1051-5812. Farb A, et al. Circulation. 2003; 108:1701–0613. Joner M, et al. J Am Coll Cardiol. 2006; 48:193-20214. Gladden LB. J Physiol. 2004; 558(1):5-3015. Ghani, QP. et al. Methods in Enzymology. 2004; 381(36):565-7516. Granada JF, SOLACI-CACI 2014

POCE: Composition of all death, all MI, all revascularizationMACE: Composite of cardiac death, MI (target vessel MI in COMFORTABLE AMI study), ci-TVR ci-TVR: Clinically indicated Target Vessel RevascularizationCD: Cardiac DeathSTEMI: ST-elevated Myocardial InfarctionIDDM: Insulin-dependent Diabetes MellitusCTO: Chronic Total Occlusion RRR: Relative Risk Reduction

A very large international prospectiveregistry5 of the BioMatrixTM Family of stentsin unselected patients demonstrates:

Low cardiac death rate at 3 years (2.1%)

Low myocardial infarction rate at 3 years (3.2%)

Low target vessel revascularization rate at 3 years (5.6%)

Low composite MACE rate at 3 years (9%)

* MACE: A Composite of cardiac death, MI, or clinically indicated TVR

Rates of very late definite stent thrombosisin all-comers randomized trialscomparing DES at 3 years of follow-up9

2.5

2.0

1.5

1.0

0.5

0

Even

t Rat

e (%

)

2.0

1.61.4

0.9

0.70.4

0.3 0.2

50

40

30

20

10

0ALL-COMERS

POCE@5 yrsLEADERSRRR=16%

STEMICD@5 yrsLEADERSRRR=75%

STEMIMACE@5 yrs

LEADERSRRR=53%

STEMIMACE@5 yrs

COMFORTABLE AMIRRR=52%

IDDMDEATH@5 yrs

LEADERSRRR=50%

CTOMACE@5 yrs

Landmark@30 daysLEADERSRRR=70%

SYNTAXSCORE >12

MACE@5 yrsLEADERSRRR=29%

Even

t Rat

e (%

)

P=0.024 P=0.007 P=0.008 P=0.0005 P=0.020 P=0.0197 P=0.021

BES SES BMS

40.4

35.1

11.8

3.1

11.9

5.8

37.7

21

35.3

13.1

30.3

22.725.7

13.1

0 6 12 18 24 30 36 Months

15

14

13

12

11

10

9

8

7

6

5

4

3

2

1

0

Even

t Rat

e (%

)

9.0

5.6

3.2

2.1

Cardiac Death MI CV-TLR MACE*

Power to Heal

Powered by

Power to Heal

High flexibilityMid section S-shape connectors

Unmatched longitudinal strengthProximal and distal straight connectors

High strength and radiopacityմեin strut cobalt chromium without any compromise

on radial strength and recoil

Excellent deliverabilityExcellent trackability and pushability

together with low tip entry profile

Exceptional overexpansion propertiesUnmatched cell openingVery low foreshortening

Are other DES drug kinetics16 adequate to cover the arterial wound healing cascade?Designed to match the entire wound healing journey of real-world patientsAlpha best-in-class performance vs. other stents1

Specifically Designed Pro-Healing PolymerNot All Polymers Are the Same

With the Same Abluminal BA9TM and PLA Coating Content,BioMatrix Alpha Has Similar BA9 Release Profileas Other BioMatrix Family Products

Biosensors’ PLA polymer degrades to naturally occurring Lactic Acid and Lactate

Lactate plays a key role in local arterial wound healing processes,mainly via enhanced VEGF production14,15

BioMatrix AlphaTM Power to Heal

Every patient heals differently and it’s not alwayspossible to predict how long a particular patient will needanti-restenotic therapy

Available data suggest that many DES-related lesions are likelyto take more than 3 to 4 months to heal completely10, 11, 12, 13

BA9 release and PLA biodegradation is optimized to coverthe entire period of arterial wound healing

In vivo presence of BA9 and biodegradable PLA with wound healing cascade overlay4

Biolimus A9TM Designed for Vascular TechnologyNot All Limus Drugs are the Same

10 times more lipophilicitythan Sirolimus

Slower metabolism of drugdue to its structure

High local bioavailability

BioMatrix AlphaTM Stent PlatformSimplifying all Complexities1

Best-in-Class Stent Platform Design1 with Unique Pro-Healing Coating... from the Pioneer in Abluminal Biodegradable Technology

Lactic Aciddegradationto Lactate

Increasedendothelial cellproliferation &

migration

IncreasedVEGF

PLAdegradation

to LacticAcid

Increaseof localLactate

BIOMATRIX ALPHATM

XIENCE ALPINETM

SYNERGYTM

ORSIROTM

RESOLUTE ONYXTM

ULTIMASTERTM0.99 mm

1.03 mm

1.37 mm

1.11 mm

1.09 mm

1.04 mm

CELL OPENINGLarge cell opening for easyside branch access

BIOMATRIX ALPHATM

XIENCE ALPINETM

RESOLUTE ONYXTM

SYNERGYTM51.76 %

36.36 %

3.85 %

11.39 %

ORSIROTM22.86 %

ULTIMASTERTM33.78 %

LONGITUDINAL COMPRESSION2

Lowest percentage change in lengthHigh confidence when recrossing the stent

BIOMATRIX ALPHATM

XIENCE ALPINETM

SYNERGYTM

ORSIROTM

RESOLUTE ONYXTM

ULTIMASTERTM4.68 %

4.39 %

3.19 %

3.31 %

4.01 %

2.95 %

RECOIL3

Lowest percentage change in diameterto avoid malapposition

ORSIRO

TM

0

20

40

60

80

100

Mas

s Re

mai

ning

(%)

9 Months0 3 6

Sirolimus PLLA

Polymer coating: PLLAAbsorption time: >12 monthsOther DES with biodegradable polymer

0

20

40

60

80

100

Mas

s Re

mai

ning

(%)

9 Months0 3 6

ABSORBTM BVS

Polymer scaffold: PLLAPolymer coating: PDLLAAbsorption time: >2 yearsBioresorbable scaffold

Everolimus PLLA

SYNERGY

TM

0

20

40

60

80

100

Mas

s Re

mai

ning

(%)

Everolimus PLGA

9 Months0 3 6

Polymer coating: PLGAAbsorption time: 4 monthsOther DES with biodegradable polymer

100%

80%

60%

40%

20%

0%

Residual BA9 in Tissue (µg) PLA Mass (µg)

Log (Time)

III - ProliferationII - Inflammation IV - Remodelling& Scar Formation

I - H

aem

osta

sis

6 months 9 months

100

Rela

tive

Lipo

phili

city

(%)

80

60

40

20

0Biolimus A9EverolimusZotarolimusSirolimus

Data

on

file

at B

iose

nsor

s